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JAVELIN Solid Tumor Trial: Avelumab Monotherapy for Metastatic Kidney Cancer

By: Joseph Fanelli
Posted: Monday, November 25, 2019

According to the results of the phase Ib JAVELIN Solid Tumor Trial, presented in the Journal for Immunotherapy of Cancer, avelumab demonstrated clinical activity and a manageable safety profile as both a first- and second-line treatment for patients with metastatic renal cell carcinoma. Ulka Vaishampayan, MD, of the Karmanos Cancer Institute at Wayne State University, Detroit, and colleagues found that patients treated with the monoclonal antibody experienced durable responses with high disease control rates.

These findings “support the foundational role of [immune checkpoint inhibitors] within combination treatment regimens for this disease,” the authors concluded.

The authors enrolled 82 patients diagnosed with metastatic renal cell carcinoma who were treatment-naive or had disease progression after a prior line of therapy. The patients received an intravenous infusion of 10 mg/kg of avelumab every 2 weeks. The patients were divided into two groups, with 62 patients receiving first-line therapy and 20 receiving second-line therapy.

The investigators found that the confirmed objective response rates for patients receiving first- and second-line treatments were 16% and 10%, respectively, with a reported duration of response of 9.9 months and not evaluable, respectively. The median progression-free survival for those who received first-line treatment was 8.3 months, compared with 5.6 months for those treated with second-line therapy; patients treated in the first-line setting exhibited a median overall survival that was not evaluable, compared with 16.9 months for those treated in the second-line setting.

Treatment-related adverse events of any grade were observed in 51 patients who received first-line treatment (82.3%) and in 14 patients who received second-line treatment (70.0%). Grade 3 or higher events were recorded in eight patients in the first-line group (12.9%) and in one patient in the second-line group (5.0%). No treatment-related deaths were reported.

Disclosure: For full disclosures of the study authors, visit jitc.biomedcentral.com.



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